Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA (PROSPECT)

April 16, 2026 updated by: Radboud University Medical Center
Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT.

Objective:

Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation)

Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up

Study design: Observational, parallel inception cohort study of patients who will undergo standard clinical care according to current guidelines.

Study population: 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT (ECT group) and 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness, quality of life and cognitive functioning.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • GGz inGeest
      • Nijmegen, Netherlands
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT and 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness and quality of life.

Description

Inclusion Criteria:

  • adult patients (>18 years) with a major depressive disorder who will either start with ECT or medication
  • failed response to at least 1 adequate dose-duration trial with antidepressants
  • moderate or severe depression (HDRS-17 >16)

Exclusion Criteria:

  • lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome
  • the presence of a concurrent significant medical condition impeding the ability to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECT group
110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment
Procedure: Electroconvulsive therapy (ECT)
ECT
Medication group
110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication as treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of treatment as measured by reduction on HDRS-17
Time Frame: change from baseline at 3 months, 6 months and 12 months
Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)
change from baseline at 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
Time Frame: change from baseline at 3 months, 6 months and 12 months
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
change from baseline at 3 months, 6 months and 12 months
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
Time Frame: change from baseline at 3 months, 6 months and 12 months
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
change from baseline at 3 months, 6 months and 12 months
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
Time Frame: change from baseline at 3 months, 6 months and 12 months
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
change from baseline at 3 months, 6 months and 12 months
COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)
Time Frame: change from baseline at 3 months, 6 months and 12 months
change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)
Time Frame: change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)
change from baseline at 3 months, 6 months and 12 months
15 words test (15WT)
Time Frame: change from baseline at 3 months, 6 months and 12 months
(15WT; Saan & Deelman, 1986)
change from baseline at 3 months, 6 months and 12 months
Verbal fluency test (e.g., Lezak et al., 2012).
Time Frame: change from baseline at 3 months, 6 months and 12 months
It typically consists of two tasks: category fluency (sometimes called semantic fluency; Benton, 1968) and letter fluency (sometimes called phonemic fluency; Newcombe, 1969). participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency).
change from baseline at 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht
St. Antonius Hospital
Elisabeth-TweeSteden Ziekenhuis
Canisius-Wilhelmina Hospital
GGZ inGeest
Parnassia

Investigators

  • Principal Investigator: Philip van Eijndhoven, PhD, MD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-13224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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